Safety data sheet according to 1907/2006/EC, Article 31

Transcription

1 Page 1/5 * SECTION 1: Identification of the substance/mixture and of the company/undertaking 1.1 Product identifier 1.2 Relevant identified uses of the substance or mixture and uses advised against Application of the substance / the mixture Dental impression material Uses advised against No further relevant information available. 1.3 Details of the supplier of the safety data sheet Manufacturer/Supplier: DENTSPLY DeTrey GmbH De-Trey-Str. 1 D Konstanz GERMANY Tel.: +49-(0) Fax: +49-(0) KonstanzDEU.info-sdb@dentsplysirona.com Further information obtainable from: - Departement Research & Development for technical information - Departement Marketing & Sales for distribution of the safety data sheets 1.4 Emergency telephone number: +49-(0) :00-17:00 (GMT + 1:00) * SECTION 2: Hazards identification 2.1 Classification of the substance or mixture Classification according to Regulation (EC) No 1272/2008 The product is not classified, according to the CLP regulation. 2.2 Label elements Labelling according to Regulation (EC) No 1272/2008 Void Hazard pictograms Void Signal word Void Hazard statements Void Additional information: As this product is a medical device in the meaning of Directive 93/42/EEC and intended for use by the end consumer and is applied in an invasive manner or body contact, it is exempt from the labelling requirements according to regulation (EC) 1272/ Other hazards Results of PBT and vpvb assessment PBT: Not applicable. vpvb: Not applicable. SECTION 3: Composition/information on ingredients 3.2 Chemical characterisation: Mixtures Description: Mixture of substances listed below with nonhazardous additions. Dangerous components: Void Additional information For the wording of the listed hazard phrases refer to section 16. * SECTION 4: First aid measures 4.1 Description of first aid measures General information No special measures required. After inhalation Supply fresh air; consult doctor in case of complaints. After skin contact Immediately wash with water and soap and rinse thoroughly. After eye contact Rinse opened eye for several minutes under running water. After swallowing If symptoms persist consult doctor. 4.2 Most important symptoms and effects, both acute and delayed No further relevant information available. Information for doctor No further relevant information available. (Contd. on page 2)

2 Page 2/5 4.3 Indication of any immediate medical attention and special treatment needed No further relevant information available. (Contd. of page 1) SECTION 5: Firefighting measures 5.1 Extinguishing media Suitable extinguishing agents CO2, powder or water spray. Fight larger fires with water spray or alcohol resistant foam. For safety reasons unsuitable extinguishing agents Water with full jet. 5.2 Special hazards arising from the substance or mixture No further relevant information available. 5.3 Advice for firefighters Protective equipment: No special measures required. SECTION 6: Accidental release measures 6.1 Personal precautions, protective equipment and emergency procedures Not required. 6.2 Environmental precautions: Do not allow to enter sewers/ surface or ground water. 6.3 Methods and material for containment and cleaning up: Absorb with liquid-binding material (sand, diatomite, acid binders, universal binders, sawdust). 6.4 Reference to other sections See Section 7 for information on safe handling See Section 8 for information on personal protection equipment. See Section 13 for disposal information. * SECTION 7: Handling and storage 7.1 Precautions for safe handling Observe normal care for working with chemicals. Handling Product is intended for dental use only. Information about fire - and explosion protection: No special measures required. 7.2 Conditions for safe storage, including any incompatibilities Storage Requirements to be met by storerooms and receptacles: Store only in the original receptacle. Information about storage in one common storage facility: Store away from foodstuffs. Further information about storage conditions: Store in dry conditions. Maximum storage temperature: 25 C Minimum storage temperature 10 C 7.3 Specific end use(s) No further relevant information available. SECTION 8: Exposure controls/personal protection Additional information about design of technical facilities: No further data; see item Control parameters Ingredients with limit values that require monitoring at the workplace: The product does not contain any relevant quantities of materials with critical values that have to be monitored at the workplace. Additional information: The lists valid during the making were used as basis. 8.2 Exposure controls Personal protective equipment General protective and hygienic measures The usual precautionary measures are to be adhered to when handling chemicals. Respiratory protection: Not required. (Contd. on page 3)

3 Page 3/5 (Contd. of page 2) Protection of hands: The glove material has to be impermeable and resistant to the product/ the substance/ the preparation. Due to missing tests no recommendation to the glove material can be given for the product/ the preparation/ the chemical mixture. Selection of the glove material on consideration of the penetration times, rates of diffusion and the degradation Material of gloves The selection of the suitable gloves does not only depend on the material, but also on further marks of quality and varies from manufacturer to manufacturer. As the product is a preparation of several substances, the resistance of the glove material can not be calculated in advance and has therefore to be checked prior to the application. Penetration time of glove material The exact break trough time has to be found out by the manufacturer of the protective gloves and has to be observed. Eye protection: Safety glasses Body protection: Protective work clothing. SECTION 9: Physical and chemical properties 9.1 Information on basic physical and chemical properties General Information Appearance: Form: Pasty Colour: According to product specification Odour: undistinguishable Odour threshold: ph-value: Change in condition Melting point/freezing point: undetermined Initial boiling point and boiling range: Undetermined. Flash point: Not applicable Flammability (solid, gaseous) Not applicable. Ignition temperature: Not applicable Decomposition temperature: Auto-ignition temperature: Product is not selfigniting. Explosive properties: Product does not present an explosion hazard. Explosion limits: Lower: Upper: Vapour pressure: Density at 20 C: 1.46 g/cm³ Relative density Vapour density Evaporation rate Solubility in / Miscibility with Water: Insoluble Partition coefficient: n-octanol/water: Viscosity: dynamic: (Contd. on page 4)

4 Page 4/5 kinematic: Solvent content: Organic solvents: 0.0 % 9.2 Other information No further relevant information available. (Contd. of page 3) SECTION 10: Stability and reactivity 10.1 Reactivity No further relevant information available Chemical stability Thermal decomposition / conditions to be avoided: No decomposition if used according to specifications Possibility of hazardous reactions No dangerous reactions known 10.4 Conditions to avoid No further relevant information available Incompatible materials: No further relevant information available Hazardous decomposition products: No dangerous decomposition products known * SECTION 11: Toxicological information 11.1 Information on toxicological effects Acute toxicity Based on available data, the classification criteria are not met. Primary irritant effect: Skin corrosion/irritation Based on available data, the classification criteria are not met. Serious eye damage/irritation Based on available data, the classification criteria are not met. Respiratory or skin sensitisation Based on available data, the classification criteria are not met. CMR effects (carcinogenity, mutagenicity and toxicity for reproduction) Germ cell mutagenicity Based on available data, the classification criteria are not met. Carcinogenicity Based on available data, the classification criteria are not met. Reproductive toxicity Based on available data, the classification criteria are not met. STOT-single exposure Based on available data, the classification criteria are not met. STOT-repeated exposure Based on available data, the classification criteria are not met. Aspiration hazard Based on available data, the classification criteria are not met. SECTION 12: Ecological information 12.1 Toxicity Aquatic toxicity: No further relevant information available Persistence and degradability No further relevant information available Bioaccumulative potential No further relevant information available Mobility in soil No further relevant information available. Additional ecological information: General notes: Do not allow undiluted product or large quantities of it to reach ground water, water course or sewage system Results of PBT and vpvb assessment PBT: Not applicable. vpvb: Not applicable Other adverse effects No further relevant information available. SECTION 13: Disposal considerations 13.1 Waste treatment methods Recommendation Smaller quantities can be disposed of with household waste. (Contd. on page 5)

5 Page 5/5 European waste catalogue chemicals other than those mentioned in (Contd. of page 4) Uncleaned packaging: Recommendation: Disposal must be made according to official regulations. SECTION 14: Transport information 14.1 UN-Number ADR, ADN, IMDG, IATA Void 14.2 UN proper shipping name ADR, ADN, IMDG, IATA Void 14.3 Transport hazard class(es) ADR, ADN, IMDG, IATA Class Void 14.4 Packing group ADR, IMDG, IATA Void 14.5 Environmental hazards: Marine pollutant: No 14.6 Special precautions for user Not applicable Transport in bulk according to Annex II of Marpol and the IBC Code UN "Model Regulation": Void Not applicable. * SECTION 15: Regulatory information 15.2 Chemical safety assessment: A Chemical Safety Assessment has not been carried out. * SECTION 16: Other information This information is based on our present knowledge. However, this shall not constitute a guarantee for any specific product features and shall not establish a legally valid contractual relationship. The attached safety data sheet covers the dangers and measures to be taken when large quantities of material are released, for example due to accidents during transport or storage by the dealer. For quantities of material typically used in clinical practice, information necessary for safe use and storage of the product is given in the DFU. Department issuing SDS: Research & Development Contact: HotLine for urgent technical support: Abbreviations and acronyms: ADR: Accord européen sur le transport des marchandises dangereuses par Route (European Agreement concerning the International Carriage of Dangerous Goods by Road) IMDG: International Maritime Code for Dangerous Goods IATA: International Air Transport Association GHS: Globally Harmonised System of Classification and Labelling of Chemicals EINECS: European Inventory of Existing Commercial Chemical Substances ELINCS: European List of Notified Chemical Substances CAS: Chemical Abstracts Service (division of the American Chemical Society) PBT: Persistent, Bioaccumulative and Toxic vpvb: very Persistent and very Bioaccumulative * Data compared to the previous version altered.